Hematopoietic Stem Cell TransplantationBE-C@TSNCT02312830
Belgian Cross-sectional Allogeneic Transplant Survivor Study
An observational study of Hematopoietic Stem Cell Transplantation and Hematopoietic Stem Cell Transplantation, Allogeneic, run by Universitaire Ziekenhuizen KU Leuven.
Trial summary
With the increasing successful use of allogeneic hematopoietic stem cell transplantation (HSCT) to cure advanced hematological disease, it becomes essential to evaluate the long-term effects of such a drastic treatment. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hematopoietic Stem Cell Transplantation, Hematopoietic Stem Cell Transplantation, Allogeneic
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients transplanted in UZ Leuven between 1992 and 2012 with an allogeneic donor (i.e. being at least 2 years post-Tx) - Hematopoietic Stem Cell Transplantation, presenting for a standard medical check up
Who may be able to join
- Ability to read and write in Dutch
- Age above 18 years at time of transplant
- Transplanted in UZ Leuven between 1992 and 2012 with an allogeneic donor (i.e. being at least 2 years post-Tx)
- Presenting for a periodic health check in UZLEUVEN from November 15th, 2014 to November 15th 2016
- Willing to provide oral and written consent
Who cannot join
- Unable to communicate fluently in Dutch
- Presenting with major visual, hearing, cognitive or psychiatric conditions precluding participation
- Presenting with relapse or other major illness, with less than 6 months expected survival
- Hospitalized for a life-threatening condition
About this study
With the increasing successful use of allogeneic hematopoietic stem cell transplantation (HSCT) to cure advanced hematological disease, it becomes essential to evaluate the long-term effects of such a drastic treatment.
This study investigates the prevalence of several demographic, psychosocial and behavioral aspects of survivorship after an allogeneic transplantation. Income, return to work, social isolation, pain, medication adherence, influenza vaccination status, alcohol use, smoking habits, drug use, healthy diet, prevention of UV exposure, physical activity, functional status/Quality of life (QoL), couple life/sexual function, depression, anxiety, spirituality and resilience will be studied.
Read the detailed description
This is a cross sectional study, where participants are interviewed and fill in a self reported survey. The interview and survey are only taken once. It is non interventional because the patients only give us extra information, which is not usually recorded in our medical records.
What is being measured
The primary outcome is the main question the study is designed to answer.
composite outcome: prevalence of several demographic, psychosocial and behavioral aspects of survivorship after an allogeneic transplantation
This is a cross sectional study, assessing several aspects of survivorship with multiple validated questionnaires (EQ5D, PHQ9, GAD, SFQ, etc). These questionnaires are only taken once in all survivors approached for the study.
Measured: The interview/survey will happen once per patient and will be offered to all transplant survivors (minimum 2 years post transplant) coming to the clinic between Nov 2014-Nov 2016. No follow up included.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02312830
- Sponsor's protocol ID
- S57284
- Acronym
- BE-C@TS
- Status last verified
- Jul 2024
- First submitted
- 15 Oct 2014
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Belgian Cross-sectional Allogeneic Transplant Survivor Study
- ClinicalTrials.gov ID
- NCT02312830
- Acronym / sponsor ID
- BE-C@TS / S57284
- Conditions
- Hematopoietic Stem Cell Transplantation, Hematopoietic Stem Cell Transplantation, Allogeneic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 9 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
With the increasing successful use of allogeneic hematopoietic stem cell transplantation (HSCT) to cure advanced hematological disease, it becomes essential to evaluate the long-term effects of such a drastic treatment.
This study investigates the prevalence of several demographic, psychosocial and behavioral aspects of survivorship after an allogeneic transplantation. Income, return to work, social isolation, pain, medication adherence, influenza vaccination status, alcohol use, smoking habits, drug use, healthy diet, prevention of UV exposure, physical activity, functional status/Quality of life (QoL), couple life/sexual function, depression, anxiety, spirituality and resilience will be studied.
Detailed description
This is a cross sectional study, where participants are interviewed and fill in a self reported survey. The interview and survey are only taken once. It is non interventional because the patients only give us extra information, which is not usually recorded in our medical records.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients transplanted in UZ Leuven between 1992 and 2012 with an allogeneic donor (i.e. being at least 2 years post-Tx) - Hematopoietic Stem Cell Transplantation, presenting for a standard medical check up
Key inclusion criteria (5 listed)
- Ability to read and write in Dutch
- Age above 18 years at time of transplant
- Transplanted in UZ Leuven between 1992 and 2012 with an allogeneic donor (i.e. being at least 2 years post-Tx)
- Presenting for a periodic health check in UZLEUVEN from November 15th, 2014 to November 15th 2016
- Willing to provide oral and written consent
Key exclusion criteria (4 listed)
- Unable to communicate fluently in Dutch
- Presenting with major visual, hearing, cognitive or psychiatric conditions precluding participation
- Presenting with relapse or other major illness, with less than 6 months expected survival
- Hospitalized for a life-threatening condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
composite outcome: prevalence of several demographic, psychosocial and behavioral aspects of survivorship after an allogeneic transplantation
Time frame: The interview/survey will happen once per patient and will be offered to all transplant survivors (minimum 2 years post transplant) coming to the clinic between Nov 2014-Nov 2016. No follow up included.
This is a cross sectional study, assessing several aspects of survivorship with multiple validated questionnaires (EQ5D, PHQ9, GAD, SFQ, etc). These questionnaires are only taken once in all survivors approached for the study.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematopoietic Stem Cell Transplantation and Hematopoietic Stem Cell Transplantation, Allogeneic, run by Universitaire Ziekenhuizen KU Leuven.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
composite outcome: prevalence of several demographic, psychosocial and behavioral aspects of survivorship after an allogeneic transplantation (time frame: The interview/survey will happen once per patient and will be offered to all transplant survivors (minimum 2 years post transplant) coming to the clinic between Nov 2014-Nov 2016. No follow up included.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024; AzTrials last refreshed its copy on 3 Nov 2026.